Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)
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|ClinicalTrials.gov Identifier: NCT02142296|
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : February 16, 2017
To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline.
- To assess the safety and tolerability of repeated intravitreal administration of Eylea in subjects with the PED subtype of neovascular AMD for a period of 1 year
- To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.
- To assess the effect of repeated intravitreal administration of Eylea on vision related quality of life in subjects with PED study type of neovascular AMD assessed using the NEI/VFQ-25 questionnaire
|Condition or disease||Intervention/treatment||Phase|
|Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration||Drug: Eylea||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 12-month, Exploratory Open-label Study of Eylea (Aflibercept) in Subjects With Retinal Pigment Epithelial Detachment Secondary to Neovascular Age-related Macular Degeneration|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
The intravitreal dose of Eylea will be 2mg (50ul) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks until week 52. This is an open-label study.
monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml
- efficacy of Eylea in patients with RPED [ Time Frame: baseline to month 12 ]visual acuity mean change from baseline compared to month 12
- safety and tolerability of repeated Eylea injection [ Time Frame: period of 1 year ]assessment of adverse events at each visit
- effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume [ Time Frame: baseline to month 12 ]using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12
- effect of repeated Eyle injections on vision related quality of life [ Time Frame: baseline to month 12 ]using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142296
|Ivey Eye Institute|
|London, Ontario, Canada, N6A 4V2|